Health TrialsbyHealthPanel

Integrated e-Health (Electronic Health) for HIV and Substance Use Disorders in Justice Involved Women

ConditionsHIVOpioid Use DisordereHealth
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorYale University

About this trial

The purpose of this 2-site (CT, AL) study is to test innovative interventions to reduce stigma and improve the pre-exposure prophylaxis (PrEP) and opioid use disorder (OUD) care continua in women involved in the criminal justice system (WICJ).

This study evaluates a newly validated PrEP decision aid and eHealth for integrated PrEP and MOUD compared to a decision aid-only for WICJ with OUD.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

woman

have access to a working mobile or landline phone

Lifetime CJ-involvement (probation, parole, intensive pretrial or community supervision, or release from prison/jail)

are confirmed HIV-negative by point-of-care 3rd generation HIV antibody test

Disqualifiers

unable or unwilling to provide informed consent

pregnant or breast-feeding

currently taking PrEP at the time of study enrollment

not comfortable conversing in English or Spanish.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Decision Aid

    Behavioral

    Decision aid for PrEP tailored for justice-involved women with opioid use disorder

  • Athena strategy

    Combination product

    eHealth for integrated PrEP/medications for opioid use disorder + decision aid

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: Athena StrategyExperimental treatment 1 intervention
Group B: Decision AidActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants who initiate PrEP

PrEP in initiation will be determined using dates of prescription and pharmacy fill and medication type (brand/generic)

Time frame
up to 6 months

Secondary outcomes

1

Number of participants who are adherent to PrEP

PrEP adherence will be assessed using a urine assay for measuring tenofovir levels (single point of care qualitative immunoassay reflecting past 48-hour adherence), where a positive test results indicates adherence.

Time frame
up to 6 months
2

Number of participants who engage in opioid use disorder treatment

The opioid use disorder treatment cascade engagement is composed of and defined by: 1) initiation of medications for opioid use disorder (or other evidence-based treatment); 2) 6-month retention on treatment; and 3) remission. The study will assess for complexity of substance use disorder treatment (e.g., court mandated vs. voluntary, behavioral vs. MOUD, residential vs. outpatient, detoxification program, etc.).

Time frame
up to 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yale University

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov
Apply now